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Fremanezumab
Fremanezumab, sold under the brand name Ajovy, is a medication used to prevent migraines in adults. It is given by injection under the skin. The most common side effect is pain and redness at the site of injection. Other side effects include allergic reactions. It is in the calcitonin gene-related peptide antagonist class of medications. It was approved for medical use in the United States in 2018, the European Union in 2019 and the UK in 2020. Medical uses Fremanezumab was shown to be effective in adults with four or more attacks per month. Adverse effects The most common adverse effects are reactions at the injection site, which occurred in 43 to 45% of people in studies (as compared to 38% under placebo). Hypersensitivity reactions occurred in fewer than 1% of patients. Interactions Fremanezumab does not interact with other antimigraine drugs such as triptans, ergot alkaloids and analgesics. It is expected to generally have a low potential for interactions because it ...
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Cluster Headache
Cluster headache (CH) is a neurological disorder characterized by recurrent severe headaches on one side of the head, typically around the eye(s). There is often accompanying eye watering, nasal congestion, or swelling around the eye on the affected side. These symptoms typically last 15 minutes to 3 hours. Attacks often occur in clusters which typically last for weeks or months and occasionally more than a year. The cause is unknown. Risk factors include a history of exposure to tobacco smoke and a family history of the condition. Exposures which may trigger attacks include alcohol, nitroglycerin, and histamine. They are a primary headache disorder of the trigeminal autonomic cephalalgias type. Diagnosis is based on symptoms. Recommended management includes lifestyle adaptations such as avoiding potential triggers. Treatments for acute attacks include oxygen or a fast-acting triptan. Measures recommended to decrease the frequency of attacks include steroid injections, ...
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Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd. (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company with headquarters in Tel Aviv, Israel. It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals. Teva Pharmaceuticals was the largest generic drug manufacturer, when it was surpassed briefly by US-based Pfizer. Teva regained its market leader position once Pfizer spun off its generic drug division in a merger with Mylan, forming the new company Viatris at the end of 2020. Overall, Teva is the 18th largest pharmaceutical company in the world. Teva's facilities are located in Israel, North America, Europe, Australia, and South America. Teva shares are listed on the Tel Aviv Stock Exchange. The company is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA). History Salomon, Levin, and Elstein Teva's earliest predecessor ...
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Calcitonin Gene-related Peptide
Calcitonin gene-related peptide (CGRP) is a member of the calcitonin family of peptides consisting of calcitonin, amylin, adrenomedullin, adrenomedullin 2 ( intermedin) and calcitonin‑receptor‑stimulating peptide. Calcitonin is mainly produced by thyroid C cells whilst CGRP is secreted and stored in the nervous system. This peptide, in humans, exists in two forms: CGRP alpha (α-CGRP or CGRP I), and CGRP beta (β-CGRP or CGRP II). α-CGRP is a 37-amino acid neuropeptide and is formed by alternative splicing of the calcitonin/CGRP gene located on chromosome 11. β-CGRP is less studied. In humans, β-CGRP differs from α-CGRP by three amino acids and is encoded in a separate, nearby gene. The CGRP family includes calcitonin (CT), adrenomedullin (AM), and amylin (AMY). Function CGRP is produced in both peripheral and central neurons. It is a potent peptide vasodilator and can function in the transmission of nociception. In the spinal cord, the function and expression of CG ...
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Calcitonin Gene-related Peptide
Calcitonin gene-related peptide (CGRP) is a member of the calcitonin family of peptides consisting of calcitonin, amylin, adrenomedullin, adrenomedullin 2 ( intermedin) and calcitonin‑receptor‑stimulating peptide. Calcitonin is mainly produced by thyroid C cells whilst CGRP is secreted and stored in the nervous system. This peptide, in humans, exists in two forms: CGRP alpha (α-CGRP or CGRP I), and CGRP beta (β-CGRP or CGRP II). α-CGRP is a 37-amino acid neuropeptide and is formed by alternative splicing of the calcitonin/CGRP gene located on chromosome 11. β-CGRP is less studied. In humans, β-CGRP differs from α-CGRP by three amino acids and is encoded in a separate, nearby gene. The CGRP family includes calcitonin (CT), adrenomedullin (AM), and amylin (AMY). Function CGRP is produced in both peripheral and central neurons. It is a potent peptide vasodilator and can function in the transmission of nociception. In the spinal cord, the function and expression of CG ...
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Calcitonin Gene-related Peptide Antagonist
Calcitonin gene-related peptide (CGRP) receptor antagonists are a class of drugs that act as antagonists of the calcitonin gene-related peptide receptor (CGRPR). Several monoclonal antibodies which binds to the CGRP receptor or peptide have been approved for prevention of migraine. Three small molecule CGRPR antagonists are approved in the U.S. as antimigraine agents. Drugs of this class have also been investigated for use in osteoarthritis. Examples Non-peptide small molecules * Ubrogepant is approved for acute treatment of migraines *Rimegepant (BMS-927711) is approved for acute and preventative treatment of migraines * Atogepant (AGN-241689) is approved for preventative treatment of migraines * Telcagepant (MK-0974), reached phase III clinical trials; development discontinued in 2011. * Olcegepant (BIBN-4096BS) is a drug candidate * BI 44370 TA (BI 44370) * MK-3207 * SB-268262 Monoclonal antibodies targeting the CGRP receptor * Erenumab (AMG-334) is approved for prevent ...
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Calcitonin Gene-related Peptide Antagonist
Calcitonin gene-related peptide (CGRP) receptor antagonists are a class of drugs that act as antagonists of the calcitonin gene-related peptide receptor (CGRPR). Several monoclonal antibodies which binds to the CGRP receptor or peptide have been approved for prevention of migraine. Three small molecule CGRPR antagonists are approved in the U.S. as antimigraine agents. Drugs of this class have also been investigated for use in osteoarthritis. Examples Non-peptide small molecules * Ubrogepant is approved for acute treatment of migraines *Rimegepant (BMS-927711) is approved for acute and preventative treatment of migraines * Atogepant (AGN-241689) is approved for preventative treatment of migraines * Telcagepant (MK-0974), reached phase III clinical trials; development discontinued in 2011. * Olcegepant (BIBN-4096BS) is a drug candidate * BI 44370 TA (BI 44370) * MK-3207 * SB-268262 Monoclonal antibodies targeting the CGRP receptor * Erenumab (AMG-334) is approved for prevent ...
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Rinat Neuroscience Corporation
Rinat Neuroscience Corporation was a privately held biotechnology company that discovered and developed antibody-based drugs, including: * Tanezumab (codenamed RN624), a monoclonal antibody against nerve growth factor for the treatment of pain * Ponezumab (codenamed RN1219), a monoclonal antibody against Beta amyloid for the treatment of Alzheimer's disease * Fremanezumab (codenamed TEV-48125, RN307 and LBR-101), a monoclonal antibody against Calcitonin gene-related peptide for the treatment of migraines * Bococizumab (codenamed RN316), a monoclonal antibody against PCSK9 designed to reduce LDL cholesterol *RN6G, a monoclonal antibody against Beta amyloid for the treatment of Geographic Atrophy in Age-Related Macular Degeneration *RN909, a monoclonal antibody antagonist of the glucagon receptor for type 2 diabetes (T2DM) *REGN4018, a novel MUC16xCD3 bispecific T-cell engager for the treatment of ovarian cancer *PF-04518600, a monoclonal antibody targeting OX40 to enhance ...
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Chinese Hamster Ovary Cell
Chinese hamster ovary (CHO) cells are an epithelial cell line derived from the ovary of the Chinese hamster, often used in biological and medical research and commercially in the production of recombinant therapeutic proteins. They have found wide use in studies of genetics, toxicity screening, nutrition and gene expression, particularly to express recombinant proteins. CHO cells are the most commonly used mammalian hosts for industrial production of recombinant protein therapeutics. History Chinese hamsters had been used in research since 1919, where they were used in place of mice for typing pneumococci. They were subsequently found to be excellent vectors for transmission of kala-azar (visceral leishmaniasis), facilitating ''Leishmania'' research. In 1948, the Chinese hamster was first used in the United States for breeding in research laboratories. In 1957, Theodore T. Puck obtained a female Chinese hamster from Dr. George Yerganian's laboratory at the Boston Cancer Research ...
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Recombinant DNA
Recombinant DNA (rDNA) molecules are DNA molecules formed by laboratory methods of genetic recombination (such as molecular cloning) that bring together genetic material from multiple sources, creating sequences that would not otherwise be found in the genome. Recombinant DNA is the general name for a piece of DNA that has been created by combining at least two fragments from two different sources. Recombinant DNA is possible because DNA molecules from all organisms share the same chemical structure, and differ only in the nucleotide sequence within that identical overall structure. Recombinant DNA molecules are sometimes called chimeric DNA, because they can be made of material from two different species, like the mythical chimera. R-DNA technology uses palindromic sequences and leads to the production of sticky and blunt ends. The DNA sequences used in the construction of recombinant DNA molecules can originate from any species. For example, plant DNA may be joined to ba ...
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US Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying f ...
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Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891). Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than billion in annual revenues. In 2020, 52% of the company's revenues came from the United States, 6% came from each of China and Japan, and 36% came from other countries. Pfizer was a component of the Dow Jones Industrial Average stock market index from 2004 to August 2020. The company ranks 64th on the Fortune 500 and 49th on the Forbes Global 2000. History 1849–1950: Early history Pfizer was founded in 1849 by Charles Pfizer and Charles F. Erhart, two cousins who ha ...
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Elimination Half-life
Biological half-life (also known as elimination half-life, pharmacologic half-life) is the time taken for concentration of a biological substance (such as a medication) to decrease from its maximum concentration ( Cmax) to half of Cmax in the blood plasma, and is denoted by the abbreviation t_. This is used to measure the removal of things such as metabolites, drugs, and signalling molecules from the body. Typically, the biological half-life refers to the body's natural cleansing through the function of the liver and through the excretion of the measured substance through the kidneys and intestines. This concept is used when the rate of removal is roughly exponential. In a medical context, half-life explicitly describes the time it takes for the blood plasma concentration of a substance to halve (''plasma half-life'') its steady-state when circulating in the full blood of an organism. This measurement is useful in medicine, pharmacology and pharmacokinetics because it helps ...
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